Reported Oct 12, 2022 · Completed
Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr.…
Dr. Reddy's Laboratories, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623
Is this the product you have?
- Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only
- Distributed byDr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16
- Lot codes and dates
Lot # ACB101Exp 03/2023
- Amount recalled
- 2,838 ampules
Where it was sold
- Nationwide
Why it was recalled
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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